FDA 510(k) Application Details - K974029

Device Classification Name	Fluorescent Immunoassay, Tobramycin   More FDA Info for this Device
510(K) Number	K974029
Device Name	Fluorescent Immunoassay, Tobramycin
Applicant	CHIRON DIAGNOSTICS CORP. 63 NORTH ST. MEDFIELD, MA 02052 US Other 510(k) Applications for this Company
Contact	THOMAS F FLYNN Other 510(k) Applications for this Contact
Regulation Number	862.3900   More FDA Info for this Regulation Number
Classification Product Code	LCR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1997
Decision Date	02/12/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review